Amgen's Lumakras Gets FDA Nod for Expanded Use in Colorectal Cancer

Zacks01-20

Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated metastatic ...

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The drug was approved in the United States in May 2021 and in the EU  in January 2022.In the past year, shares of Amgen have dropped 12.2% compared with the industry’s decline of 14.1%.Lumakras’ approval for the mCRC indication was based on data from the phase III CodeBreaK 300 study, which evaluated Lumakras plus Vectibix versus the investigator's choice of therapy in KRAS G12C–mutated mCRC.Data from the CodeBreaK 300 study also showed that treatment with Lumakras plus Vectibix demonstrated favorable ov","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","BK4581":"高盛持仓","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0058720904.USD":"联博国际健康护理基金A","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","BK4213":"石油与天然气的勘探与生产","VYGR":"Voyager Therapeutics Inc","CSTL":"Castle Biosciences, Inc.","BK4599":"减肥药","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","CTMX":"CytomX","LU0122379950.USD":"贝莱德世界健康科学A2","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","BK4585":"ETF&股票定投概念","BK4534":"瑞士信贷持仓","BK4139":"生物科技","BK4533":"AQR资本管理(全球第二大对冲基金)","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","BK4211":"区域性银行","BK4566":"资本集团","PFS":"Provident Financial Services Inc","BK4196":"保健护理服务","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU2242652126.USD":"FIDELITY FUNDS GLOBAL DIVIDENDS PLUS \"A\" (USD) INC","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4195":"互助储蓄与抵押信贷金融服务","SOC":"Sable Offshore Corp.","LU1983299246.USD":"SCHRODER ISF HEALTHCARE INNOVATION \"A\" (USD) ACC","BK4588":"碎股","AMGN":"安进","LU2112291526.USD":"BGF WORLD HEALTHSCIENCE \"A4\" (USD) INC","LU2242646821.SGD":"Fidelity Global Dividend Plus A-MINCOME(G)-SGD","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC"},"translate_title":"安进的Lumakras获得FDA批准扩大用于结直肠癌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VYGR":1,"SOC":1,"PFS":1,"AMGN":1,"CTMX":1,"CSTL":1},"content_text":"Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated metastatic colorectal cancer (mCRC).\nThe regulatory body approved Lumakras plus Vectibix for treating KRAS G12C-mutated mCRC in adult patients who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.\nLumakras is presently approved for treating advanced or metastatic non-small cell lung cancer (NSCLC). The drug was approved in the United States in May 2021 and in the EU (marketed as Lumykras) in January 2022.\nIn the past year, shares of Amgen have dropped 12.2% compared with the industry’s decline of 14.1%.\nImage Source: Zacks Investment Research\nLatest Nod Based on AMGN's CodeBreaK 300 Study\nLumakras’ approval for the mCRC indication was based on data from the phase III CodeBreaK 300 study, which evaluated Lumakras plus Vectibix versus the investigator's choice of therapy in KRAS G12C–mutated mCRC.\nData from the CodeBreaK 300 study showed that treatment with Lumakras plus Vectibix led to superior progression-free survival (PFS) versus the investigated standard-of-care (SOC) in KRAS G12C-mutated mCRC – the study’s primary endpoint.\nThe study evaluated two different doses of Lumakras (960 mg daily or 240 mg daily) in combination with Vectibix versus the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC.\nPer management, the combo of Lumakras plus Vectibix is now the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to demonstrate superior PFS versus the investigated SOC.\nData from the CodeBreaK 300 study also showed that treatment with Lumakras plus Vectibix demonstrated favorable overall survival and overall response rate in treating KRAS G12C-mutated mCRC – the study's key secondary endpoints.\nMore Updates on AMGN's Lumakras\nIn the first nine months of 2024, Lumakras recorded sales worth $265 million, reflecting an increase of 30.5% on a year-over-year basis.\nLabel expansion studies on Lumakras in earlier lines of therapy, which have the potential to significantly expand the currently addressable patient population, are ongoing.\nAmgen is also evaluating Lumakras in phase I and phase II studies for treating NSCLC as monotherapy and in combination with other therapies. Approval for expanded indications can potentially boost the drug’s sales in future quarters.\nAMGN's Zacks Rank & Stocks to Consider\nAmgen currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. VYGR, CytomX Therapeutics, Inc. CTMX and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Voyager Therapeutics’ loss per share have narrowed from $1.72 to $1.48 for 2025. In the past year, shares of VYGR have plunged 32.8%.\nVYGR’s earnings beat estimates in each of the trailing four quarters, the average surprise being 120.87%.\nIn the past 60 days, estimates for CytomX Therapeutics’ loss per share have narrowed from 46 cents to 35 cents for 2025. In the past year, shares of CTMX have declined 48.5%.\nCTMX’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 115.70%.\nIn the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 26%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nAmgen Inc. (AMGN) : Free Stock Analysis Report\nVoyager Therapeutics, Inc. (VYGR) : Free Stock Analysis Report\nCytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.2","shortVersion":"4.30.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2505287123"}